BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1915074 · Received December 1, 2010

    Report

    Report Number
    3007566237-2010-10074
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: BRONTE-STEWART H, LOUIE S, BATYA S, HENDERSON JM. CLINICAL MOTOR OUTCOME OF BILATERAL SUBTHALAMIC NUCLEUS DEEP-BRAIN STIMULATION FOR PARKINSON'S DISEASE USING IMAGE-GUIDED FRAMELESS STEREOTAXY. NEUROSURGERY. OCT 2010;67(4):1088-1093; DISCUSSION 1093. SUMMARY: THE AUTHORS REPORTED ON A GROUP OF 20 MEN AND 11 WOMEN WITH PARKINSON'S DISEASE (MEAN AGE OF 62 YRS). TWENTY-EIGHT SUBJECTS HAD BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) AND 3 HAD UNILATERAL STN DBS USING A FRAMELESS APPROACH. THE AUTHORS INDICATED THAT THEIR OUTCOMES RESULTS ARE COMPARABLE TO THOSE REPORTED WITH THE USE OF THE FRAMED-BASED TECHNIQUE. ALL PTS HAD POSTOPERATIVE CT SCANS WITHIN 6 HRS OF THE PROCEDURE; MILD PNEUMOCEPHALUS WAS COMMON, BUT THERE WERE NO INTRACRANIAL HEMORRHAGES. REPORTABLE EVENT: THIS REPORT IS FOR ONE PT WHO DEVELOPED POSTOPERATIVE INFECTION REQUIRING DBS LEAD REMOVAL, INTRAVENOUS ANTIBIOTICS, AND SUBSEQUENT REIMPLANTATION. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| IMPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| EXPLANTED:| EXPLANTED: